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Staff Acceptance of Remote Patient Monitoring on Intensive Care Unit (SARPI)

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ClinicalTrials.gov Identifier: NCT03514173
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Felix Balzer, Charite University, Berlin, Germany

Brief Summary:

The subject of the observation study with accompanying employee survey is the evaluation of a patient remote monitoring system (Vital Sync from Medtronic, hereinafter abbreviated as "Vital Sync") in intensive care medicine.

The aim of this research project is to determine whether the use of Vital Sync on an intensive care unit is accepted by medical and nursing staff and can be integrated into everyday work as an additional visualisation and analysis tool.


Condition or disease Intervention/treatment
Remote Patient Monitoring on Intensive Care Unit Device: Remote Patient Monitoring

Detailed Description:

In intensive care medicine, patient monitoring has become a standard that has led to a significant improvement in patient safety in recent decades. At the international level, minimum requirements for patient monitoring have been set out in guidelines and recommendations that represent milestones in patient safety, such as the Helsinki Declaration for Anaesthesiology and the Vienna Declaration for Intensive Care. With advances in digital health, there are new options for patient monitoring that may improve patient safety.

The concept of the Internet of Things has recently gained in importance. While the personal computer (PC) was long regarded as a prerequisite for making technologies accessible to people, the use of computer-supported electronic infrastructures has become ubiquitous. Today, more and more everyday devices are equipped with electronic circuits (microchip, memory chip), blurring earlier boundaries between hardware and software. In an intensive care unit - an environment with high operational reliability - ubiquitous computing means that the processing and visualization of medical data must not be limited to typical workstations at the patient's bedside. Instead, the accessibility of data relevant to medical decisions should result from clinical workflows, leading to the targeted provision of information as needed.

Although various remote patient monitoring systems from commercial providers are already available, little is known about how they can effectively support clinical processes. At the Charité, the working group "Data Science in Perioperative Care" of the Clinic for Anaesthesiology with focus on operative intensive care Charité - Universitätsmedizin Berlin, Campus Virchow and Campus Mitte is systematically evaluating the integration of such novel technologies with special consideration of the socio-technical dimension.

In the pre-implementation phase, 15 ICU staff members (physicians, nurses and respiratory therapists) will be involved into a semi-structured interview study. Results from this pre-implementation study will be validated via two independent surveys involving ICU staff members (n>100). In the post-implementation phase, two semi-structured interview studies will be conducted with key stakeholders of the ICU until data saturation is reached (n=5-10). The focus of this post-implementation interview studies will be to analyse the usability of the installed remote patient monitoring system as well as the success of the implementation and its contributing factors.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Other
Official Title: Analysis of Sociotechnical Acceptance and Workflow Integration of a Remote Patient Monitoring Device on an Intensive Care Unit
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Intervention Details:
  • Device: Remote Patient Monitoring
    Use of remote patient monitoring


Primary Outcome Measures :
  1. Acceptance of Remote Patient Monitoring Device on Intensive Care Unit [ Time Frame: One year ]
    Acceptance of Remote Patient Monitoring Device (measured by the Likert scale on the question "What was the benefit of the new system for you?" 0=no benefit; 5=very high benefit)


Secondary Outcome Measures :
  1. Structural Data of Intensive Care Unit [ Time Frame: One year ]
    Number and arrangement of ICU beds (in numbers e.g. 1,2,3,4....)

  2. Structural Data of Intensive Care Unit [ Time Frame: One year ]
    utilization of ICU (in percent e.g. 50%, 40%...)

  3. Structural Data of Intensive Care Unit [ Time Frame: One year ]
    number of ventilated patients

  4. Structural Data of Intensive Care Unit [ Time Frame: One year ]
    care per patient ratio (nurse per patient, e.g. 1:1)

  5. Structural Data of Intensive Care Unit [ Time Frame: One year ]
    doctor per patient (doctor per patient, e.g. 1:1)

  6. Structural Data of Intensive Care Unit [ Time Frame: One year ]
    working hours of staff (e.g. 7am until 8pm)

  7. Use of medical technology on Intensive Care Unit [ Time Frame: One year ]
    emotions when using Vital Sync (on a Likert Scale 0=very annoyed, 5=very happy)

  8. Use of medical technology on Intensive Care Unit [ Time Frame: One year ]
    Usability (Validated by John Brooke in 1986: System User Scale using Likert Scales) (0=bad usability, 100=very good usability)

  9. Usage of Vital Sync [ Time Frame: One year ]
    usage time (in minutes) of Vital Sync (in min. per day)

  10. Usage of Vital Sync [ Time Frame: One year ]
    usage frequency of Vital Sync (e.g. x time per day)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

From the Department for Anaesthesiology and operative Intensive Care, Charité - Universitätsmedizin Berlin, Campus Virchow- Klinikum and Campus Charité Mitte, Germany

  • physicians
  • specialist nurses
  • respiratory therapists or respiratory therapists
Criteria

Inclusion criteria:

From the Department for Anaesthesiology and operative Intensive Care, Charité - Universitätsmedizin Berlin, Campus Virchow- Klinikum and Campus Charité Mitte, Germany

  • physicians
  • specialist nurses
  • respiratory therapists or respiratory therapists

Exclusion criteria:

  • Rejection of participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514173


Contacts
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Contact: Akira Poncette, Dr. 004930631 ext 185 Akira-sebastian.poncette@charite.de

Locations
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Germany
Charité - Universitätsmedizin, Klinik für Anästhesiologie m.S. operative Intensivmedizin Recruiting
Berlin, Germany, 10117
Contact: Felix Balzer, Prof.    004930651 ext 166    felix.balzer@charite.de   
Contact: Akira Poncette, Dr.    004930631 ext 185    Akira-sebastian.poncette@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Felix Balzer, Prof. Charite University, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Felix Balzer, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03514173     History of Changes
Other Study ID Numbers: SARPI
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No